A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
NCT ID: NCT01970098
Last Updated: 2018-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
374 participants
INTERVENTIONAL
2013-10-09
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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KPS-0373
KPS-0373, High dose
28 weeks
KPS-0373, Low dose
28 weeks
Placebo
Placebo
28 weeks
Interventions
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KPS-0373, High dose
28 weeks
KPS-0373, Low dose
28 weeks
Placebo
28 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
20 Years
ALL
No
Sponsors
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Kissei Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Tatsuro Takei
Role: STUDY_DIRECTOR
Locations
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Multiple Locations, , Japan
Countries
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References
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Nishizawa M, Onodera O, Hirakawa A, Shimizu Y, Yamada M; Rovatirelin Study Group. Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials. J Neurol Neurosurg Psychiatry. 2020 Mar;91(3):254-262. doi: 10.1136/jnnp-2019-322168. Epub 2020 Jan 14.
Other Identifiers
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KPS1301
Identifier Type: -
Identifier Source: org_study_id